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Investigation Highlights Serious Problems at Compounding Pharmacy Linked to Meningitis Outbreak

The debate is heating up regarding the role of compounding pharmacies in our health care system and the necessary oversight over compounding pharmacies in the wake of the devastating meningitis outbreak caused by contaminated steroid shots.

Compounding pharmacies are those drug manufacturers that mix customized medications based on prescriptions. Under the current system, state and federal agencies share oversight over compounding pharmacies, but  courts often disagree about state and federal authority over compounding companies, which has “hampered [the FDA’s] ability to act to protect patients and prevent, rather than just react to, safety concerns,” FDA Commissioner Margaret A. Hamburg said in this Washington Post article.

Last month, the FDA urged Congress to grant the agency additional oversight authority of compounding agencies.  Republication lawmakers weren’t so quick to agree with the FDA, however, arguing that the FDA has adequate oversight and enforcement authority.

While it remains somewhat uncertain whether Congress will increase the FDA’s oversight and enforcement authority, it is clear that compounding pharmacies play a major role in the nation’s health care system and that any shortcomings at these pharmacies can lead to disastrous results.

The massive meningitis outbreak caused by contaminated steroid shots produced at New England Compounding Center (NECC), which prompted the congressional hearings last month, has resulted in more than 460 injuries and 32 deaths. Aside from the latest meningitis outbreak, Bloomberg reports that FDA records documented 23 deaths and 86 serious injuries since 2001 associated with compounding pharmacies. The deaths included additional meningitis illnesses and overdoses of a numbing cream used for laser hair removal.

Bloomberg reports that  at least 16 specialty pharmacies that mix their own medicines were warned by U.S. regulators for major violations since 2003, some similar to those found at NECC. Moreover, according to a New York Times article, “contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.”

In the past three years, six of the major manufacturers of sterile injectable drugs have been issued warnings by the FDA about serious violations of manufacturing rules, says that the Times article. These manufacturing facilities are subject to rigorous inspections by the federal government, whereas compounding pharmacies are generally overseen by the states.

Not only is Congress taking the meningitis outbreak seriously, but so are federal officials. In fact, a federal grand jury in Boston has begun investigating NECC, including issuing subpoenas to former employees of the compounding pharmacy, which seems to indicate that federal prosecutors are pursuing potential criminal charges against NECC. NECC has also been named as the defendant in twelve lawsuits filed to date in Massachusetts.

If you have been injured by the meningitis outbreak or another unsafe pharmaceutical drug, contact the Chicago product liability law firm of Steinberg, Goodman & Kalish at (800) 784-0150 to learn more about a possible legal claim.

 

Steinberg Goodman & Kalish  (www.sgklawyers.com) is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (800) 784-0150 or (312) 782-1386.